WELCOME TO POLITICO PRO’s Morning Health Care, your tip sheet for what’s happening in European health policy. We’ve got EMA news not likely to make drugmakers feel warm and cuddly, oncologists fired up about drug prices in the U.S. and more. Thanks as always to Peter O’Donnell for invaluable help.

— BIG CHANGES COMING IN DRUG STUDIES

MORE STUDIES ON KIDS: Drugmakers looking for approval in Europe will have to do more studies in kids on treatments for diseases including Parkinson’s disease and a type of atherosclerosis, under an opinion set to be adopted by the European Medicines Agency.

The changes mark a shift away from waivers that refer only to specific diseases, which, says EMA, can mean overlooking the potential for the use of the medicines in children more generally. So eight class waivers have been scrapped, covering liver and intrahepatic bile duct carcinoma, kidney and renal pelvis carcinoma, coronary atherosclerosis, peripheral atherosclerosis, vascular dementia and vascular cognitive disorder / impairment, non-juvenile Parkinson disease, Huntington chorea, and amyotrophic lateral sclerosis.

Fifteen have been updated, mainly extending coverage of cancers. Only nine remain unchanged. For any new medicine without an explicit exemption, a plan describing how the medicines should be studied in children has to be submitted early in the development process, and a marketing authorization application must show studies have been conducted in line with the plan. Read more here: http://politi.co/1g8g935

WHAT WILL IT MEAN FOR PHARMA? EFPIA said it was still studying the changes, but Christopher Milner, director of research at the Tufts Center for the Study of Drug Development in the U.S., told POLITICO: “I cannot imagine that drug companies are feeling very warm and tickly about this.”

More studies have to mean more money, over the longer term. A big challenge in these trials, he said, was finding enough patients to make the results meaningful.

— DRUG PRICES TAKE MORE FIRE

CANCER DOCTORS CRY FOUL ON DRUG PRICING: More than 100 American oncologists banded together in an editorial for the Mayo Clinic Proceedings journal on Wednesday, protesting what they see as exorbitant cancer drug prices, the Wall Street Journal reports. A peak into their frustrations? Patients, the doctors say, “have to make difficult choices between spending their incomes [and liquidating assets] on potentially lifesaving therapies or forgoing treatment to provide for family necessities” and, occasionally, they will choose the latter: http://on.wsj.com/1foC4Ch

Doctors are the latest group to take aim at high drug prices in the U.S. Also in the growing chorus: at least six state legislatures, one angry Senate Finance committee, and even a former president, says the New York Times: http://nyti.ms/1Kmxt

— CAPITAL NEWS

WILL GENERICS HELP SAVE GREECE? Bloomberg takes a look at whether pushing docs to prescribe more generics will have save the country and their fledgling health care system. Greece is last among its peers in using generics to save on pharmaceutical costs. http://bloom.bg/1gQoU1J

PORTUGAL MOVES TOWARDS STRICT ABORTION LAWS: In a heated pre-recess legislative session, Portuguese lawmakers passed a bill late Wednesday that would require women seeking abortions to pay fees and to receive mandatory psychological counseling and family planning advice — an action critics reportedly called a “disgrace,” aimed at shaming women in the predominantly Catholic country. The law, still awaiting presidential approval, would be an amendment to a 2007 referendum that legalized abortions of up to 10 weeks: http://yhoo.it/1foynfH

BELGIUM WEIGHS DECENTRALIZED, DE-MEDICALIZED HIV TESTS: Belgian Superior Health Council recommendations, published on Thursday, outlined limited scenarios where people would be able to screen for HIV/AIDS without the presence of a doctor — signaling a possible loosening of Belgian restrictions, which only allow individuals to test in clinics with physicians. A spokesperson for Health Minister Maggie De Block on Thursday told POLITICO the ministry was “looking into” possible legal changes that would permit more decentralized and de-medicalized testing, under conditions like those laid out in the report, but she added that government financing for these testing programs remains off the table for now.

UK WATCHDOG CLEARS STROKE DRUG SAFETY: A review by U.K.’s drug safety watchdog finds alteplase is safe to treat strokes, amid concerns about fatal bleeding. One prominent expert said the study was biased, with the panel made up of docs in the field. The BBC has more: http://bbc.in/1el3fgo

— THE UK’S KIDS

EATING DISORDERS START EARLY FOR BRITISH KIDS: How early do we see signs of potential eating disorders in children? Even kids as young as eight can experience body image consciousness and insecurity, putting them at risk of developing eating disorders, says a major UK study published Thursday. More, from the Guardian: http://bit.ly/1g8dciV

STUDENTS TRY “VAPING” OVER SMOKING: While the number of English children between 11 and 15 years old trying cigarettes has consistently fallen over the years, more youngsters are trying out “vaping,” or using e-cigarettes to smoke, according to official Health and Social Care Information Centre figures. Here’s the BBC’s breakdown of the numbers: http://bbc.in/1Jh7Qgx

— DODGY DRUGS

SUCCESS CLAIMED IN MOVES TO PREVENT PHARMA FRAUD: The European Medicines Verification Organization, a joint venture between drugmakers and others in industry, boasted of passing a milestone with its first “hub connection” with a member state, Germany’s securPharm. The group is developing databases linked to point-of-dispensing systems that will allow pharmacists to check, in real time, a unique code affixed to each product to meet the requirements set down in 2011 legislation aiming to prevent falsified meds from making it into the supply chain. Read more from POLITICO’s earlier story here: http://politi.co/1BRtXbu

— DRUG COMPETITION

ROCHE SAYS IT CAN HANDLE BIOSIMILAR RIVALS: The chief executive at the biggest European cancer drugmaker said it is equipped to handle the coming expiration of its patents on its pricey biotech drugs like Herceptin and Rituxan, with treatments using cancer immunotherapy coming. Still, the FT quotes Citigroup analyst Andrew Baum as believing that “investors are underestimating the threat posed by biosimilars to Roche,” forecasting sales of the three biggest drugs dropping by 50 percent over the next decade or so. http://on.ft.com/1VA2lOO

SHIRE STILL LOOKING FOR DEALS: Reporting a 9 percent jump in sales, the U.K.-listed company’s CEO says it is still looking for acquisitions as it strives to become a bigger biotech player, the FT reports. http://on.ft.com/1RWjK4Y

— EMA LOOKING FOR ORDINARY FOLKS

CLIMBING ABOARD THE EMA TRANSPARENCY TRAIN: Men (and women) in the street (or the closest that the EU gets to that concept) have a new chance to play a part in the workings of the European Medicines Agency from early next year, and anyone wanting to get involved needs to apply by September 30. The EMA has just invited applications from “civil society representatives” (the EU doesn’t like to call a spade a spade) to join two committees for the next three years. One invitation relates to the Pharmacovigilance Risk Assessment Committee, which has spots for four members. Two will represent patients’ groups (they will take it in turns to sit), and two will put the views (also alternatively) of healthcare professionals. They will take over from the current civil society representatives at the end of February 2016.

They will play a role in the application of the tougher EU drug monitoring legislation that came into effect over the last three years in a bid to avert scandals over adverse effects from inappropriate medicines — like the French Mediator. The committee also comprises national delegates and six scientific experts. The aim of bringing non-experts on board is to ensure that the views of patients and doctors are taken into account in the way the rules are applied: http://politi.co/1CSDGz8

ANGLES ON ADVANCED THERAPIES: The other invitation relates to the agency’s Committee for Advanced Therapies, and here the search is for four clinicians and four representatives of patients’ organizations. This committee deals with products based on gene therapy, somatic cell therapy and tissue engineering. For both committees, the workload is between two to four days a month in London, as well as preparation of meetings, and only expenses are provided.

—MISC.

WHO PUTS WORD OUT ON HEPATITIS: Timed to World Hepatitis Day, the WHO is stressing the need for urgent action to combat hepatitis, including the need for sterile injections, to test donated blood and the use of the hepatitis B vaccine, which is recommended for children. Hepatitis B and C jointly cause about 80 percent of all liver cancer deaths and kill close to 1.4 million people every year, according to the WHO.

AMERICANS LOVE GMOS: The U.S. House passed a bill preventing mandatory labeling of GMOs in food, in a victory for the agricultural industry. Its prospects in the Senate are unclear. http://reut.rs/1SELo1B